Effect of Ergonomic Classroom Furniture on the Printing Legibility of Elementary Students With Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
ergonomic chair and desk (Q-Learn Classic Chair and Q-Learn Desk)
ergonomic desk and chair (Q-Learn Desk)
Sponsored by
About this trial
This is an interventional supportive care trial for Cerebral Palsy focused on measuring handwriting, child, primary school, posture, assistive device
Eligibility Criteria
Inclusion Criteria:
- primary diagnosis of cerebral palsy
- functional status of Gross Motor Function Classification System Level I or II
Exclusion Criteria:
- genetic disorder;
- attention-deficit hyperactivity disorder; or,
- pervasive developmental disorder
Sites / Locations
- Bloorview Research Institute, Bloorview Kids Rehab
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
Minnesota Handwriting Assessment
Secondary Outcome Measures
Full Information
NCT ID
NCT00465686
First Posted
April 23, 2007
Last Updated
May 5, 2008
Sponsor
Holland Bloorview Kids Rehabilitation Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00465686
Brief Title
Effect of Ergonomic Classroom Furniture on the Printing Legibility of Elementary Students With Cerebral Palsy
Official Title
Ergonomic Classroom Furniture and the Printing Legibility of Elementary School Students With CP
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Holland Bloorview Kids Rehabilitation Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this pilot study is to gather the data needed to do a larger research study to determine whether children with cerebral palsy print better sitting at an ergonomically-designed, custom-fitted school desk or at an oversized, standard school desk.
Detailed Description
This pilot study will allow us to gather information for a high-quality randomized controlled trial to study the efficacy of ergonomic school furniture as a remedial handwriting intervention for young students with cerebral palsy. We will conduct the study in two parts. In the first part, 30 children with Gross Motor Function Classification System (GMFCS) Level I and II cerebral palsy will each provide manuscript handwriting samples using two different school furniture configurations. A blinded assessor will score the legibility of handwriting samples using the Minnesota Handwriting Assessment (MHA) as a primary outcome measure. In the second part, seven occupational therapy experts will attend a focus group to help us determine the minimal clinically important difference score for the MHA. We will use the data collected to determine the sample size requirements for a proposed randomized controlled trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
handwriting, child, primary school, posture, assistive device
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
ergonomic chair and desk (Q-Learn Classic Chair and Q-Learn Desk)
Other Intervention Name(s)
Q-Learn Classic Chair and Q-Learn Desk
Intervention Description
ergonomic school chair and desk adjusted to fit the child user as per the manufacturer's instructions
Intervention Type
Device
Intervention Name(s)
ergonomic desk and chair (Q-Learn Desk)
Other Intervention Name(s)
Q-Learn Desk
Intervention Description
child sits on chair and desk for 5 minutes, then provides handwriting sample at one desk, then repeats this for the other desk
Primary Outcome Measure Information:
Title
Minnesota Handwriting Assessment
Time Frame
5-10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
primary diagnosis of cerebral palsy
functional status of Gross Motor Function Classification System Level I or II
Exclusion Criteria:
genetic disorder;
attention-deficit hyperactivity disorder; or,
pervasive developmental disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen E Ryan, MSc, PEng
Organizational Affiliation
Bloorview Research Institute, Bloorview Kids Rehab
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bloorview Research Institute, Bloorview Kids Rehab
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 1R8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Effect of Ergonomic Classroom Furniture on the Printing Legibility of Elementary Students With Cerebral Palsy
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